FDA Drug Recalls

Recalls / Class II

Class IID-719-2014

Product

carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832

Affected lot / code info
carBAMazepine ER, Capsule, 200 mg has the following code Pedigree: AD32764_14, EXP: 5/14/2014.

Why it was recalled

Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.

Recalling firm

Firm
Aidapak Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity
229 Capsules
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated
2013-07-02
FDA classified
2014-01-16
Posted by FDA
2014-01-22
Terminated
2014-02-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-719-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls